Manager, Manufacturing - Novato, CA | Biospace
Get Our FREE Industry eNewsletter

Manager, Manufacturing

BioMarin Pharmaceutical Inc.

Apply
Location:
Novato, CA
Posted Date:
11/30/2016
Position Type:
Full time
Job Code:
12509
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Description    
       BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
           
       BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites,  provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.  Come join our team and make a meaningful impact on patients' lives.
       
       SUMMARY
       
       BioMarin's Novato commercial manufacturing operations produce recombinant enzyme replacement proteins for rare genetic disorders. The manager will be responsible for leading a team of  up to 4 supervisors and 50+ technicians, developing staff capabilities, creating a culture of safety, maintain training objectives, compliance and collaboration while implementing process improvements where applicable. The manager leads the department with responsibilities for Clinical Manufacturing, with a focus on either bacterial fermentation or downstream operations, while ensuring compliance with current Good Manufacturing Practices (cGMP), policies and safety practices. The position requires being available off shift to support operations
       
       RESPONSIBILITIES
       
       The Manufacturing Manager is responsible for an assigned area within a plant (Upstream, Downstream or Process Services). Collaborates with support groups to ensure accurate and well managed transfer of process changes/improvements to floor operations. Integrates best practices, where appropriate, into manufacturing. Oversees the planning, implementation and execution of manufacturing operations for new and/or existing products and technologies in a cGMP environment.
       
       Leadership
        ~BIO       #LI-SM1      
           Accountable and oversight for the daily operations of an area that requires making appropriate decisions including the trouble shooting of equipment, action to process deviations and schedule adjustments with minimal oversight
             
           Accomplishes tasks through direct & effective management of staff
             
           Interact with department leaders to ensure production objectives are met
             
           Accomplishes results through professional staff and/or employees
             
           Sets project timeframes and priorities based on objectives with effective tracking and management of progress
             
           Provides guidance and technical advice and becomes actively involved as required
             
           Manages a team of supervisors and/or professionals
             
           Contributes to the standards around which others operate
           
           Process Knowledge
             
           Experience with automated process equipment and control
             
           Working knowledge with disposable systems, filtration, CIP & SIP
             
           Experience with troubleshooting and problem solving with process and equipment
             
           Experience with Buffer and Media operations
             
           Support the closure of manufacturing discrepancies and change requests
             
           Knowledge and experience in all aspects of GMP manufacturing
             
           Ability to troubleshoot, identify issues and support resolutions with technical groups
             
           Effectively communicates relevant information with team & department
             
           Ensure consistent product quality through implementation of effective systems and collaboration with key support groups (QA, MSG, Eng, Fac, etc.)
             
           Broad technical knowledge in area of responsibility for and provide technical instruction on new/improved processes to appropriate audiences, primarily Manufacturing personnel
           
           People
           
           • Involved in hiring and monitoring process to maintain staffing levels
           
              • Provides effective leadership through:
           
                  - Managing performance and expectations of direct reports, team and self
           
               - Manage performance issues, development and policies
           
                 - Ensure the use of safe and compliant work practices and behaviors
           
           Quality
           
           • Own and approve deviations and change requests within assigned work area.
             
           Initiate and own required Corrective and Preventative actions and lead change control actions
             
           Manage required actions with department and collaboration with support groups to meet quality commitments and established timelines
           
           • Provide technical expertise to resolve manufacturing issues. Interact with support groups to ensure targets are met and product and process comply with cGMPs
           
           • Owner of Standard Operating Procedures and Batch Records
             
           Ensure staffing levels and skill sets are maintained and training is in compliance
             
           Complete understanding and adherence to cGMP's as related to commercial operations
             
           Lead or oversee teams responsible for drafting standard operating procedures
           
           Strategic Influence
           
           General Look-Ahead: 1 year
             
           Monitor and manage all aspects of performance in an assigned manufacturing area
             
           Translates business plans and organizational goals into actionable objectives
             
           Influences approach for operations at campaign and daily execution
             
           Adheres to and executes policies and guidelines that directly affect work activities
             
           Champion self-initiated projects and drive area of control within context of defined priorities
           
           Business
             
           Experience various business systems (Process historian,CMMS, LIMS, Trackwise, ERP, MES, etc.)
             
           Lead trending and communication of key department metrics
             
           Identify and drive opportunities for process & business optimization
           
           Contribution
             
           Accountable for operations and results of a assigned area in production plant
             
           Ability to independently manage work and assigned projects
             
           Responsible for projects that span multiple functional areas
             
           Receive assignments in the form of objectives with goals and steps to meet as defined
             
           Work is reviewed by management to measure meeting of defined objectives
             
           Establishes and influences operations policies with focus on alignment across manufacturing plants when appropriate
             
           Communicate, interact and influence with peers and plant leadership
             
           Provide oversight of the GMP Cleanings and gowning management of 3 GMP facilities
           

Requirements

EXPERIENCE
           
           Required Skills:
             
           8+ years of directly related industry experience, including at least 4+ years with proven leadership role
             
           Ability to independently manage work, actions and expectations is essential
             
           Experience with process development, process transfer, validation and multi-product operations
             
           Strong organizational, collaborating and communication skills
             
           May have in excess of 4 direct reports overseeing a group of 50+ to manage
           
           EDUCATION
             
           B.S. degree in Life Sciences, Engineering, Applied Physics, etc., or acceptable equivalent combination of education and experience.
           
           WORK ENVIRONMENT/PHYSICAL DEMANDS
           
           The employee may frequently be required to sit and talk or hear.  The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell.  The employee must occasionally lift and/or move up to 25 pounds.  Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.